国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
GRANISETRON HYDROCHLORIDE (UNII: 318F6L70J8) (GRANISETRON - UNII:WZG3J2MCOL)
Cipla USA Inc.
GRANISETRON HYDROCHLORIDE
GRANISETRON 0.1 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Granisetron Hydrochloride Injection is a serotonin-3 (5-HT3 ) receptor antagonist indicated for: • The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. Granisetron Hydrochloride Injection is contraindicated in patients with known hypersensitivity (eg. anaphylaxis, shortness of breath, hypotension, urticaria) to the drug or to any of its components. Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in pregnant rats at intravenous doses up to 9 mg/kg/day (54 mg/m2 /day, 146 times the recommended human dose based on body surface area) and pregnant rabbits at intravenous doses up to 3 mg/kg/day (35.4 mg/m2 /day, 96 times the recommended human dose based on body surface area) and have revealed no evidence of impaired fertility or harm to the fetus due to granisetron. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not alw
Granisetron Hydrochloride Injection, 0.1 mg/mL (free base), is supplied in 1 mL Single-Use Vials. CONTAINS NO PRESERVATIVES. NDC 69097-195-67 (package of 1 Single-Use Vial) NDC 69097-195-68 (package of 5 Single-Use Vials) Storage Store single-use vials at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.] Do not freeze. Protect from light. Retain in carton until time of use.
Abbreviated New Drug Application
GRANISETRON HYDROCHLORIDE- GRANISETRON HYDROCHLORIDE INJECTION CIPLA USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE GRANISETRON HYDROCHLORIDE INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GRANISETRON HYDROCHLORIDE INJECTION. GRANISETRON HYDROCHLORIDE INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1993 RECENT MAJOR CHANGES Warnings and Precautions (5.5) 08/2014 INDICATIONS AND USAGE Granisetron Hydrochloride Injection is a serotonin-3 (5-HT ) receptor antagonist indicated for: The prevention of nausea and/or vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin. (1) DOSAGE AND ADMINISTRATION Prevention of chemotherapy-induced nausea and vomiting (2.1): Recommended dosage is 10 mcg/kg intravenously within 30 minutes before initiation of chemotherapy Pediatric patients (2 to 16 years): Recommended dosage is 10 mcg/kg DOSAGE FORMS AND STRENGTHS Injection 0.1 mg/mL (free base). (3) CONTRAINDICATIONS Hypersensitivity to granisetron or to any of its components. (4) WARNINGS AND PRECAUTIONS Granisetron hydrochloride does not stimulate gastric or intestinal peristalsis and should not be used instead of nasogastric suction. (5.1) QT prolongation has been reported with granisetron hydrochloride. Use with caution in patients with pre-existing arrhythmias or cardiac conduction disorders. (5.2) Hypersensitivity reactions, such as anaphylaxis, shortness of breath, hypotension, and urticaria, may occur in patients with known hypersensitivity to other selective 5-HT receptor antagonists. (5.3) Serotonin syndrome has been reported with granisetron, alone but particularly with concomitant use of serotonergic drugs. (5.4) ADVERSE REACTIONS Most common adverse reactions: Chemotherapy-induced nausea and vomiting (≥3%): Headache, and constipation (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT CIPLA LIMITED AT 1-866-604-3268 OR FDA AT 1-800- FDA-1088 OR WWW.FDA.GOV 阅读完整的文件